The U.S. Food and Drug Administration will host a webinar on June 5, 2024, to provide an overview of draft guidance documents concerning the regulation of in vitro diagnostic devices (IVDs).
The webinar will review the scope and key elements of two draft guidance documents: “Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564” and “Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency.” Attendees have until May 24 to submit questions about the draft guidance documents for possible discussion during the webinar. Questions must be directed to CDRHWebinars@fda.hhs.gov. The FDA will accept public comments for each of the draft guidance documents until July 5, before final versions of the guidance documents are completed.
These draft guidance documents come after the FDA issued its final rule amending the regulation of laboratory-developed tests (LDTs) — defined by the FDA as IVDs intended for clinical use and designed, manufactured, and used within a single clinical laboratory — designating all IVDs as medical devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD is a laboratory.
Registration before the webinar is not required. Webinar details and materials, including a link to sign on, can be found here.
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